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Efficacy and Safety Study With MYL-1401H and Neulasta

Breast Neoplasms Clinical Trial

Official title:
Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

Clinical Trial Summary

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.

Clinical Trial Description

After successful screening, eligible patients will be randomly allocated to one of the two study arms, either receiving MYL-1401H or Neulasta. Randomization is 2:1 to MYL-1401H or Neulasta, respectively. Subjects will receive first of six cycles of background therapy (Docetaxel, Doxorubicin, Cyclophosphamide [TAC]) on day 1. Treatment with study drug (either MYL-1401H or Neulasta) is scheduled on Day 2 of each cycle, at least 24 hours after chemotherapy administration. Duration of each cycle is 3 weeks. Follow-up visit is scheduled 24 weeks after the first administration of study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02467868
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 3
Start date March 2015
Completion date February 2016
View Details
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